Genomic Testing for Breast Cancer

(FLEX Trial)

Recruiting at 124 trial locations

Overseen By Michelle Landon, MS, CGC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Agendia

Disqualifiers: Metastatic, Recurrent, Stage 0, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Varies

30000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to understand breast cancer by examining the genes involved in the disease. It uses tests called MammaPrint and BluePrint to analyze the full set of genes in patients with stage I to III breast cancer. The goal is to identify patterns that could help doctors select better treatments for patients in the future. It suits individuals with a new primary breast tumor who have already undergone these specific gene tests. As an unphased study, this trial offers participants a unique opportunity to contribute to groundbreaking research that could shape future breast cancer treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that MammaPrint and BluePrint testing is safe for breast cancer patients?

Research has shown that MammaPrint and BluePrint tests are generally safe for patients. These tests analyze genes to assess the risk of breast cancer recurrence. They are not treatments and do not involve medication, so they lack the side effects associated with drugs. Instead, they use a sample from a breast tumor to gather information.

Patients have found these tests easy to handle because they are non-invasive, meaning they do not enter the body or cause harm. No reports of negative effects from the testing process itself exist. Therefore, participants in studies using these tests can feel confident about their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MammaPrint and BluePrint testing because these approaches offer a personalized look at breast cancer. Unlike traditional treatments that often rely on a one-size-fits-all method, these tests analyze the activity of specific genes in cancer cells, providing a detailed genetic profile. This genetic insight helps doctors tailor treatment plans more precisely, potentially improving outcomes and avoiding unnecessary treatments. By using a full-genome data chip, these tests give a comprehensive view of the tumor's characteristics, helping to guide more informed decisions about therapy.

What evidence suggests that MammaPrint and BluePrint testing could be effective for breast cancer?

Research has shown that the MammaPrint and BluePrint tests aid in treating breast cancer. In this trial, all participants will undergo both MammaPrint and BluePrint testing using the full-genome testing data chip. MammaPrint examines 70 genes to assess whether early-stage breast cancer patients are at low or high risk of recurrence. This information assists doctors in deciding if chemotherapy is necessary. Studies indicate that patients identified as high risk by MammaPrint often opt for chemotherapy, with 91% remaining cancer-free after five years. Additionally, MammaPrint can identify patients who appear high risk based on clinical factors but are low risk genetically, allowing them to potentially avoid chemotherapy and still achieve favorable outcomes. When combined with MammaPrint, BluePrint offers further insights into the tumor, aiding in the creation of personalized treatment plans. ^{3 6 7 8 9}

Who Is on the Research Team?

Joyce O'Shaughnessy, MD

Principal Investigator

Texas Oncology - Baylor Charles A. Sammons Center

William Audeh, MD

Principal Investigator

Agendia, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female)

Informed consent form signed on the same day or before enrollment

New primary lesion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MammaPrint and BluePrint Testing

All patients receive MammaPrint and BluePrint testing using the full-genome testing data chip

At time of treatment

Treatment

Treatment is at the discretion of the physician adhering to NCCN approved regimens

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

1 year post-treatment, 3, 5, and 10 years post diagnosis

What Are the Treatments Tested in This Trial?

Interventions

• BluePrint
• Full-Genome Testing
• MammaPrint

How Is the Trial Designed?

Group I: MammaPrint and BluePrint testing Experimental Treatment 1 Intervention

All patients will receive MammaPrint and BluePrint testing using the full-genome testing data chip. Treatment will be at the discretion of the physician while adhering to NCCN guidelines.

Who Is Running the Clinical Trial?

Agendia

Lead Sponsor

Trials

18

Recruited

44,100+

Citations

1. agendia.com agendia.com/agendia-to-reveal-novel-breast-cancer-outcome-data-identifying-genomic-risk-and-treatment-disparities-among-diverse-patient-population-at-2025-asco-annual-meeting/

Agendia to Reveal Novel Breast Cancer Outcome Data ... – The data reveal that patients aged ≥70 with MammaPrint High Risk tumors were less likely to receive chemotherapy. However, older women with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9299843/

MammaPrint and BluePrint comprehensively capture the ... MammaPrint® (MP) is a 70‐gene signature that stratifies early‐stage breast cancer patients into low‐ and high risk of distant relapse.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.511

Association of MammaPrint index and 3-year outcome ... Association of MammaPrint index and 3-year outcome of patients with HR+HER2- early-stage breast cancer treated with chemotherapy with or without ...

4. agendia.com agendia.com/study-shows-half-of-early-stage-breast-cancer-patients-may-safely-avoid-chemotherapy/

Study Shows Half of Early-Stage Breast Cancer Patients ... Of the 208 patients who were determined to be 'high risk,” 81 percent chose chemotherapy and 91% were disease-free after five years. “MammaPrint ...

5. academic.oup.com academic.oup.com/jncics/article/9/5/pkaf079/8228535

early breast cancer: FLEX Registry real-world data | JNCI ... MINDACT has proven that MammaPrint can identify clinically high risk, genomically low risk patients who have excellent outcomes without chemotherapy, but it was ...

6. agendia.com agendia.com/mammaprint-blueprint-and-full-genome-data-linked-with-clinical-data-to-evaluate-new-gene-expression-profiles-flex-a-real-world-dataset-and-investigator-initiated-protocols-in-esbc/

MammaPrint, BluePrint, and Full-genome Data Linked with ... The FLEX Study (NCT03053193) is aggregating a large, real-world dataset, linking comprehensive clinical and full genome expression data with a ...

7. agendia.com agendia.com/mammaprint/

MammaPrint Breast Cancer Testing & Recurrence Risk MammaPrint genomic test analyzes the 70 most important genes and provides clear answers for risk of breast cancer recurrence.

8. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/3466

MammaPrint, BluePrint, and Full-Genome Data Linked With ... The participant's full genome data will be used for research purposes only. MammaPrint is used to determine the patient's risk for distant metastasis (spreading ...

9. georgiacancerinfo.org georgiacancerinfo.org/clinical-trials/detail/5091

MammaPrint, BluePrint, and Full-genome Data Linked With ... Tests the safety of a drug in healthy volunteers or subjects with indications. The aim is to find the best dose of a new drug with the fewest side effects ...